(1997; 248 pages) [French]
1.8 Terms of reference of the regulatory authority
The formal terms of reference of a national drug regulatory authority are determined by statute and regulation. Legislation relating to pharmaceutical products has developed piecemeal in many countries, and there are obvious advantages in bringing matters concerned with their regulation under one law. For example, it is important to correlate laws relating to the control of narcotic and psychotropic substances with requirements for product registration. If comprehensive overhaul of the legal system is impracticable, control within the existing framework through regulations specifically related to the registration of pharmaceutical products offers advantages of economy and time-saving. Whichever option is chosen, regulatory authorities require the flexibility to respond to changing circumstances imposed by the evolution of pharmaceutical science. In general terms, the authority should be vested with legal powers to:
(a) issue, vary and revoke licences for pharmaceutical products on grounds of quality, safety, and efficacy;
(b) secure the subsequent safe and effective use of each product by controlling, through the terms of the licence, the content of all labelling (including package inserts, associated prescribing information and advertising) and the channels through which the product may legitimately be supplied; and
(c) inspect and license all manufacturing premises, importing agents, wholesalers and distributors, hospital dispensaries, independent pharmacies, and other retail outlets to ensure that they comply with prevailing regulations and guidelines.